中国药房2024，Vol.35Issue(17)：2082-2087,6.DOI:10.6039/j.issn.1001-0408.2024.17.05
肿瘤专科医院超说明书用药评价体系的构建与应用评价
Construction and application evaluation of off-label drug use evaluation system in cancer hospital
摘要
Abstract
OBJECTIVE To provide reference for strengthening the standardized management of off-label drug use in cancer hospitals.METHODS The evaluation system for off-label drug use was established to standardize the application,approval,and filing process for off-label drug use in our hospital.The changes in off-label drug application quantity,proportion,disease category and drug category in our hospital were compared before(October 1st,2021-September 30th,2022)and after(October 1st,2022-September 30th,2023)the establishment of the evaluation system;drug items supported by high-level evidence screened by pharmacy department were analyzed statistically.RESULTS The number of off-label drug use applications in our hospital had gradually increased,from 306 pieces in the fourth quarter of 2021 to 3 828 pieces in the third quarter of 2023.In the year before the construction of the evaluation system,there were a total of 4 482 applications for off-label drug use,and in the year after the construction of the evaluation system,there were 11 840 applications for off-label drug use.After the construction of the evaluation system,the proportion of unregistered off-label drug use significantly decreased,compared to the same period last year(P＜0.05).Among them,there were no unregistered applications for off-label drug use for digestive system tumors,head and neck tumors,and radioactive drugs;lymphoma,breast tumors,urogenital system tumors,cytotoxic drugs and new anti-tumor drugs all had a decrease of over 70%in unregistered off-label drug applications.Twenty-seven off-label drug use items related to 19 drugs supported by high-level evidence were screened by the pharmacy department of our hospital,among which 25 items were drug use beyond indication.CONCLUSIONS The establishment of off-label drug use evaluation system in cancer hospital is helpful to the rational use and refined management of clinical anti-tumor drugs.关键词
超说明书用药/抗肿瘤药物/评价体系/循证证据Key words
off-label drug use/anti-tumor drugs/evaluation system/evidence-based reference分类
医药卫生引用本文复制引用
刘婧琳,宋晓坤,王伟平,王洪涛,高宁,张超,周西蓓,吴春暖,陆璐,张洁..肿瘤专科医院超说明书用药评价体系的构建与应用评价[J].中国药房,2024,35(17):2082-2087,6.基金项目
天津市医学重点学科(专科)建设项目(No.TJYXZDXK-009A) （专科）
天津医科大学肿瘤医院科研项目药学、检验、影像专项基金(No.Y2205) （No.Y2205）
